Smartphone-delivered Scheduled Smoking With Compliance Facilitation as an Adjunct Cessation Therapy: a Feasibility Study

NCT05763771 | Active Not Recruiting

• 2 other identifiers: 2022-0772NCI-2023-01983
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

To collect user experience data for a smartphone app that is designed to help people reduce or quit smoking and to learn if the app, combined with nicotine patches, can help people quit smoking.

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

• Application (App) Usability Questionnaire

  Scale Scores (1-5) 1-strongly disagree, 2-disagree, 3-neither disagree nor agree, 4-agree and 5-strongly agree

  through completion of study; an average of 1 year.

Study Arms (2)

Part 1

EXPERIMENTAL

Participants will use the app for 4 weeks, during which participants will follow a smoking schedule on the app to help you reduce your cigarette consumption

Behavioral: Smart Phone App; Other: NIcotine Patches

Part 2

EXPERIMENTAL

Participants will also use the app for the duration of the study (about 3 months). Participants will be asked to record your smoking using the app and complete online surveys

Behavioral: Smart Phone App; Other: NIcotine Patches

Interventions

Smart Phone App BEHAVIORAL

Collection of data

Part 1; Part 2

NIcotine Patches OTHER

Place on the skin

Part 1; Part 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 years old or older
• Smoking: an average of 10 or more cigarettes, little cigars, or cigarillos combined per day within the past 30 days preceding the phone screen
• Expired carbon monoxide (CO): \> 6 ppm
• Can install and run the study app on their Android smartphone, or agree to use the study smartphone loaned from the research team
• Agree to return the study smartphone if the participant loans one from the research team
• Willing to reduce smoking (Aim 1)
• Seeking smoking cessation treatment (Aim 2)
• Fluency in spoken and written English
• Agree to be treated via telehealth (live audio-video conference and phone) and to be contacted via text and/or email
• Provide informed consent and agree to all assessments and study procedures
• Willing to refrain from the use of other nicotine/tobacco products for the duration of the study
• Willing to refrain from the use of marijuana, prescription medications not prescribed to the participant, and illegal drugs

You may not qualify if:

• Taking psychotropic, anticonvulsive, or narcotic medication
• Meet criteria for a current major depressive episode or suicidality according to the PHQ (indicated by a score of 10 or higher).
• Involved in current and imminent (within the next 45 days) smoking cessation activity
• Women who are pregnant or breastfeeding
• Shares the same address as a currently enrolled participant
• Unwilling to use or allergic to nicotine patches (Aim 2)
• Considered by the investigator to be an unsuitable or unstable candidate, such as those who appear to have cognitive impairment, and those who reside in a shelter, group/recovery facility, or treatment facility
• Any plans to move out of the state in the next 6 months
• Using marijuana, prescription medications not prescribed to the participant, and illegal drugs on a daily basis
• Have experienced abnormal heart rhythms or cardiovascular disease, such as stroke, chest pain, and heart attack, in the last month (Aim 2)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Smoking

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Yong Cui, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 10, 2023
• Study Start: February 15, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)